BEUDAMED
    FDA Recall Terminated

    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.

    Recall: Z-1619-2015 · Initiated April 14, 2015

    Recall

    Recall Number
    Z-1619-2015
    Event Number
    71027
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 14, 2015
    Posted
    May 15, 2015
    Terminated
    December 12, 2017
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.

    Reason

    Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.

    Action

    Integra initiated this recall by sending an Urgent Voluntary Medical Device Recall Letter/Recall Acknowledgement Form dated 4/14/15 via traceable courier service to their affected customers.

    Distribution

    Worldwide Distribution.

    Quantity

    273 monitors